Environmental Exposure and Neurological Diseases Questionnaire

NCT02916966 | Completed

• 1 other identifier: D06019
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research is particularly relevant to the National ALS Registry and public environmental health issues because it addresses the potential environmental causes of sporadic ALS. The research will develop an ALS surveillance program in Ohio that can be compared with the national and State-Metro Surveillance Programs of the National ALS Registry, and novel methodologies to determine the role of the cyanobacterial toxin, BMAA (beta-methylamino-L-alanine), and other environmental toxins/toxicants as risk factors for ALS. This work will advance the mission of the Centers for Disease Control Agency for Toxic Substances and Disease Registry (CDC ATSDR) National ALS Registry by offering data on ALS cases in Ohio that address public health concerns over the effects of chronic exposure to cyanobacterial blooms in Lake Erie.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Questionnaire for Environmental Exposures, Toxins, and Neurological Disease

  1 year

Study Arms (4)

ALS Patients in Case-Control

ALS patients enrolled by Cleveland Clinic Foundation (CCF)

Other: Patient Registry

Non-neurodegenerative patients in case control

Non-neurodegenerative patients enrolled by CCF

Other: Patient Registry

Non-neurodegeneration population in population control

Non-neurodegenerative general population enrolled by ABS mailing system from DHMC

Other: Patient Registry

ALS Patients in State of OH

ALS registry of all cases in Ohio

Other: Patient Registry

Interventions

Patient Registry OTHER

Patient Registry

ALS Patients in Case-Control; ALS Patients in State of OH; Non-neurodegeneration population in population control; Non-neurodegenerative patients in case control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. ALS patients in case-control at CCF 2. Non-neurodegenerative patients in case control at CCF 3. Non-neurodegenerative general population in Ohio 4. ALS patient registry in Ohio

You may qualify if:

• ALS
• Non-neurodegenerative controls
• Can willingly give consent
• Over 18 years of age

You may not qualify if:

• Cannot give consent
• Under 18 years of age

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 28, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

US (1)